Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denosumab | Active Comparator | denosumab 60 mg subcutaneously every 6 months |
|
| zoledronic acid | Active Comparator | zoledronic acid 5 mg intravenously once a year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab 60 MG/ML Prefilled Syringe [Prolia] | Drug | denosumab 60 mg subcutaneously every 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone mineral density after one year of treatment | Dual-energy X-ray absorptiometry (DXA) | one year |
| CTX after 3 months of treatment | Unit of Measure: pmol/L | 3 months |
| Corrected calcium after 3 months of treatment | Unit of Measure: mmol/L | 3 months |
| Bone mineral density after two years of treatment | Dual-energy X-ray absorptiometry (DXA) | two years |
| CTX after 12 months of treatment | Unit of Measure: pmol/L | one year |
| CTX after 24 months of treatment | Unit of Measure: pmol/L | two years |
| PINP after 3 months of treatment | Unit of Measure: µg/L | 3 months |
| PINP after 12 months of treatment | Unit of Measure: µg/L | one year |
| PINP after 24 months of treatment | Unit of Measure: µg/L |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Postmenopausal women
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tomaz Kocjan, MD, PhD | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology Department | Ljubljana | 1000 | Slovenia |
Bone mineral density, bone turnover markers and basic laboratory results will be shared.
The data will become available in 3 years. They will be available for 5 years.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D049950 | Hyperparathyroidism, Primary |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001851 | Bone Diseases, Metabolic |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zoledronic Acid | Drug | zoledronic acid 5 mg intravenously once a year |
|
|
| two years |
| Bone-specific alkaline phosphatase (BAP) after 3 months of treatment | Unit of Measure: µg/L | 3 months |
| Bone-specific alkaline phosphatase (BAP) after 12 months of treatment | Unit of Measure: µg/L | one year |
| Bone-specific alkaline phosphatase (BAP) after 24 months of treatment | Unit of Measure: µg/L | two years |
| Corrected calcium after 12 months of treatment | Unit of Measure: mmol/L | one year |
| Corrected calcium after 24 months of treatment | Unit of Measure: mmol/L | two years |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |